NCT07179653进行中（未招募）2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Chronic Hepatitis B Patients
Grand Theravac Life Sciences (Nanjing) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年1月22日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- HBsAg clearance rate
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety of TVAX- 008 injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II clinical trial in subjects with HBSAg levels of 0.05 to 100 IU/mL, including CHB patients previously treated with siRNA/ASO drugs and treatment-naive HBV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- aged 18~65 ； Serum HBsAg positive ≥ 6 months； HBeAg negative；
排除标准
- •Treatment with interferon or pegylated interferon within 12 weeks prior to first use of investigational product; or planned treatment with interferon or pegylated interferon during the trial;
研究组 & 干预措施
TVAX-008
Experimental
干预措施: TVAX-008 (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
HBsAg clearance rate
时间窗: Week49
次要结局
未报告次要终点
研究者
研究点 (1)
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